Browsing by Author "Spanos, Marina"

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    A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials
    (Drug Safety, 2018-01-09) Coates, Margaret; Spanos, Marina; Parmar, Pooja; Chandrasekhar, T; Sikich, Lin
    Pediatric psychotropic prescription rates are rising, emphasizing the need for careful monitoring of drug safety in this population. Currently, no standardized assessments are used in clinical trials for adverse event (AE) elicitation focused on long-term drug treatment in pediatric patients. Despite a lack of standardized AE elicitation methods in psychiatric clinical trials, it is clear that psychiatric medications have developmentally dependent AEs that differ from those observed in adults. In this review, we discuss the use of general inquiry elicitation, drug-specific checklists, and systematic elicitation scales for AE reporting in pediatric psychopharmacology trials. The checklists evaluated include the Barkley Side Effect Rating Scales (SERS), the Pittsburg side effect rating scale, and the Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS) checklist. The systematic assessment scales discussed include the Systematic Assessment for Treatment of Emergent Events (SAFTEE) and the Safety Monitoring Uniform Report Form (SMURF). We review the advantages and disadvantages of each method and discuss the need for optimal assessment of AEs. AE instruments that are created and utilized for pediatric psychiatric trials must begin to incorporate symptoms that are relevant to this population and account for the nature of the disorders to better characterize treatment-emergent AEs and monitor long-term safety.
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    Autism, Psychosis, or Both? Unraveling Complex Patient Presentations
    (Child and Adolescent Psychiatric Clinics of North America, 2019-01-01) Chandrasekhar, Tara; Copeland, John Nathan; Spanos, Marina; Sikich, Linmarie
    © 2019 Elsevier Inc. Autism spectrum disorders (ASDs) and schizophrenia spectrum disorders co-occur at elevated rates. Although these conditions are diagnostically distinct, they share multiple clinical features and genetic risk factors. This article describes the epidemiologic features and clinical manifestations of psychosis in individuals with ASDs, while also discussing shared genetic risk factors and affected brain regions. Components of a diagnostic assessment, including a thorough developmental, behavioral, medical, and psychiatric history, will be reviewed. The authors highlight the manifestations of catatonia in this population and note the shared features between catatonia and ASDs. Finally, treatment approaches and areas for future study are suggested.
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    Genetic and epigenetic signatures associated with plasma oxytocin levels in children and adolescents with autism spectrum disorder
    (Autism Research) Siecinski, Stephen K; Giamberardino, Stephanie N; Spanos, Marina; Hauser, Annalise C; Gibson, Jason R; Chandrasekhar, Tara; Trelles, Maria Del Pilar; Rockhill, Carol M; Palumbo, Michelle L; Cundiff, Allyson Witters; Montgomery, Alicia; Siper, Paige; Minjarez, Mendy; Nowinski, Lisa A; Marler, Sarah; Kwee, Lydia C; Shuffrey, Lauren C; Alderman, Cheryl; Weissman, Jordana; Zappone, Brooke; Mullett, Jennifer E; Crosson, Hope; Hong, Natalie; Luo, Sheng; She, Lilin; Bhapkar, Manjushri; Dean, Russell; Scheer, Abby; Johnson, Jacqueline L; King, Bryan H; McDougle, Christopher J; Sanders, Kevin B; Kim, Soo-Jeong; Kolevzon, Alexander; Veenstra-VanderWeele, Jeremy; Hauser, Elizabeth R; Sikich, Linmarie; Gregory, Simon G
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    Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder.
    (The New England journal of medicine, 2021-10) Sikich, Linmarie; Kolevzon, Alexander; King, Bryan H; McDougle, Christopher J; Sanders, Kevin B; Kim, Soo-Jeong; Spanos, Marina; Chandrasekhar, Tara; Trelles, MD Pilar; Rockhill, Carol M; Palumbo, Michelle L; Witters Cundiff, Allyson; Montgomery, Alicia; Siper, Paige; Minjarez, Mendy; Nowinski, Lisa A; Marler, Sarah; Shuffrey, Lauren C; Alderman, Cheryl; Weissman, Jordana; Zappone, Brooke; Mullett, Jennifer E; Crosson, Hope; Hong, Natalie; Siecinski, Stephen K; Giamberardino, Stephanie N; Luo, Sheng; She, Lilin; Bhapkar, Manjushri; Dean, Russell; Scheer, Abby; Johnson, Jacqueline L; Gregory, Simon G; Veenstra-VanderWeele, Jeremy

    Background

    Experimental studies and small clinical trials have suggested that treatment with intranasal oxytocin may reduce social impairment in persons with autism spectrum disorder. Oxytocin has been administered in clinical practice to many children with autism spectrum disorder.

    Methods

    We conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder. Participants were randomly assigned in a 1:1 ratio, with stratification according to age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a total target dose of 48 international units daily. The primary outcome was the least-squares mean change from baseline on the Aberrant Behavior Checklist modified Social Withdrawal subscale (ABC-mSW), which includes 13 items (scores range from 0 to 39, with higher scores indicating less social interaction). Secondary outcomes included two additional measures of social function and an abbreviated measure of IQ.

    Results

    Of the 355 children and adolescents who underwent screening, 290 were enrolled. A total of 146 participants were assigned to the oxytocin group and 144 to the placebo group; 139 and 138 participants, respectively, completed both the baseline and at least one postbaseline ABC-mSW assessments and were included in the modified intention-to-treat analyses. The least-squares mean change from baseline in the ABC-mSW score (primary outcome) was -3.7 in the oxytocin group and -3.5 in the placebo group (least-squares mean difference, -0.2; 95% confidence interval, -1.5 to 1.0; P = 0.61). Secondary outcomes generally did not differ between the trial groups. The incidence and severity of adverse events were similar in the two groups.

    Conclusions

    This placebo-controlled trial of intranasal oxytocin therapy in children and adolescents with autism spectrum disorder showed no significant between-group differences in the least-squares mean change from baseline on measures of social or cognitive functioning over a period of 24 weeks. (Funded by the National Institute of Child Health and Human Development; SOARS-B ClinicalTrials.gov number, NCT01944046.).